What side effects are associated with this type of intervention?

Common treatments for cognitive functioning include nutritional supplements, cognitive enhancers, and stress reduction techniques. Nutritional supplements like omega-3 fatty acids are generally well-tolerated but can cause minor gastrointestinal issues. Cognitive enhancers, such as certain medications, may lead to side effects like insomnia, headaches, and gastrointestinal disturbances. Stress reduction techniques, including mindfulness and cognitive behavioral therapy, are typically safe but may cause temporary emotional discomfort as individuals confront stressors. Overall, these treatments are considered to have a favorable safety profile, but individual responses can vary.

What prior FDA approvals exist?

The FDA has approved several treatments aimed at improving cognitive functioning, particularly for conditions like Alzheimer's disease. Notable examples include cholinesterase inhibitors such as donepezil, rivastigmine, and galantamine, which work by increasing levels of acetylcholine in the brain. Memantine, an NMDA receptor antagonist, is another approved drug that helps regulate glutamate activity to improve cognitive function. While there are fewer FDA-approved treatments specifically for cognitive enhancement in healthy individuals, some nutritional supplements like omega-3 fatty acids and certain vitamins have been studied for their potential cognitive benefits. Additionally, stress reduction techniques such as mindfulness and exercise are recognized for their positive impact on cognitive health, although they are not FDA-regulated treatments.

What other types of research exist?

Promising novel alternatives for cognitive functioning in 2024 include: 1) Nutritional supplementation with high-dose intravenous ascorbic acid, which has shown potential in cancer care and may have cognitive benefits. 2) Cognitive enhancers such as neurofeedback, which has been reviewed for pediatric ADHD and may be applicable to cognitive functioning. 3) Stress reduction techniques like guided imagery and progressive muscle relaxation, which have been effective in cancer-related pain and may improve cognitive clarity and mental health outcomes.

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Dietary Supplement

Health and Wellness Products for Cognitive Functioning

N/A

Waitlist Available

Led By Emily K. Pauli, PharmD

Research Sponsored by Radicle Science

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6 weeks

Summary

This trial tests health products on adults aged 21+ in the U.S. who want better concentration. Participants will take either the product or an inactive substance without knowing which one they have. The study will monitor their mental clarity and other health outcomes.

Who is the study for?

Adults over 21 in the U.S. who want to improve their concentration can join this study. They must be willing to take an unknown product (active or placebo) and have internet access. Excluded are those with liver/kidney disease, heart issues incompatible with ingredients, current clinical trial participants, pregnant/breastfeeding individuals, heavy drinkers, and certain medication users.

What is being tested?

The Radicle Clarity study is testing various health and wellness products against placebos to see if they improve mental clarity. Participants won't know if they're getting a real product or a placebo until the end of the randomized and blinded trial.

What are the potential side effects?

Since specific side effects aren't listed for these health products, general possible side effects may include digestive discomfort, allergic reactions, headaches or dizziness; however individual experiences will vary.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~6 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in cognition (mental clarity)

Secondary study objectives

Change in anxiety

Change in energy (fatigue)

Change in executive functioning

+4 more

Trial Design

13Treatment groups

Experimental Treatment

Placebo Group

Group I: Active Product 5.2Experimental Treatment1 Intervention

Clarity Product Form 5 - active product 2

Group II: Active Product 5.1Experimental Treatment1 Intervention

Clarity Product Form 5 - active product 1

Group III: Active Product 4.3Experimental Treatment1 Intervention

Clarity Product Form 4 - active product 3

Group IV: Active Product 4.2Experimental Treatment1 Intervention

Clarity Product Form 4 - active product 2

Group V: Active Product 4.1Experimental Treatment1 Intervention

Clarity Product Form 4 - active product 1

Group VI: Active Product 3.1Experimental Treatment1 Intervention

Clarity Product Form 3 - active product 1

Group VII: Active Product 2.1Experimental Treatment1 Intervention

Clarity Product Form 2 - active product 1

Group VIII: Active Product 1.1Experimental Treatment1 Intervention

Clarity Product Form 1 - active product 1

Group IX: Placebo Control 4Placebo Group1 Intervention

Clarity Product Form 4 - control

Group X: Placebo Control 3Placebo Group1 Intervention

Clarity Product Form 3 - control

Group XI: Placebo Control 5Placebo Group1 Intervention

Clarity Product Form 5 - control

Group XII: Placebo Control 2Placebo Group1 Intervention

Clarity Product Form 2 - control

Group XIII: Placebo Control 1Placebo Group1 Intervention

Clarity Product Form 1 - control

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Clarity Active Study Product 1.1 Usage

2023

N/A

~4830

Clarity Active Study Product 4.3 Usage

2023

N/A

~4830

Clarity Active Study Product 2.1 Usage

2023

N/A

~4830

Clarity Active Study Product 4.2 Usage

2023

N/A

~4830

Clarity Active Study Product 5.1 Usage

2023

N/A

~4830

Clarity Active Study Product 5.2 Usage

2023

N/A

~4830

Clarity Active Study Product 3.1 Usage

2023

N/A

~4830

Clarity Active Study Product 4.1 Usage

2023

N/A

~4830

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Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for cognitive functioning include nutritional supplementation, cognitive enhancers, and stress reduction techniques. Nutritional supplements provide essential nutrients that support brain health, such as omega-3 fatty acids and antioxidants. Cognitive enhancers, like nootropics, improve neurotransmitter function and synaptic plasticity, enhancing memory and learning. Stress reduction techniques, such as mindfulness and relaxation therapy, lower cortisol levels, which can improve mental focus and reduce cognitive decline. These mechanisms are crucial for cognitive functioning patients as they address various aspects of brain health, potentially leading to improved mental clarity and overall cognitive performance.